FDA product code MXZ: Immunohistochemistry Assay, Antibody, Progesterone Receptor
MXZ is the FDA product code for immunohistochemistry assay, antibody, progesterone receptor. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel. FDA has cleared 13 510(k) submissions under MXZ, from 11 different applicants. The average 510(k) review took 141 days (median 119). FDA has posted 3 recalls for MXZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Immunohistochemistry Assay, Antibody, Progesterone Receptor |
| Device class | Class II |
| Regulation | 21 CFR 864.1860 |
| Review panel | PA — Pathology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MXZ
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 196 |
| 2018 | 1 | 30 |
| 2020 | 1 | 91 |
Compare with all 510(k) review times · Search every MXZ clearance
Top MXZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Leica Biosystems Newcastle, Limited | 2 | 2018-12-07 |
| Dako North America, Inc. | 2 | 2016-05-03 |
| Leica Biosystems Newcastle, Ltd. | 1 | 2020-03-06 |
| Dako Denmark A/S | 1 | 2017-12-21 |
| Ventana Medical Sytems, Inc. | 1 | 2011-11-16 |
6 more applicants have MXZ clearances. See the full list in Caduvo.
Most recent MXZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K193393 | Leica Biosystems Newcastle, Ltd. | BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). | 2020-03-06 | 91 |
| K183102 | Leica Biosystems Newcastle, Limited | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody | 2018-12-07 | 30 |
| K170005 | Dako Denmark A/S | FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis) | 2017-12-21 | 352 |
| K171753 | Leica Biosystems Newcastle, Limited | BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 | 2017-07-21 | 39 |
| K160922 | Dako North America, Inc. | FLEX Monoclonal Rabbitt Anti-Human Estrogen Receptor a, Clone EP1, Ready-to-Use (Link); FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 636, Ready-to-Use (Link) | 2016-05-03 | 29 |
Recalls for MXZ devices
3 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-02.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code MXZ?
MXZ is the FDA product code for immunohistochemistry assay, antibody, progesterone receptor. It is a Class II device, regulated under 21 CFR 864.1860 and reviewed by the Pathology panel.
What device class is MXZ?
Class II, regulation 21 CFR 864.1860. Typical premarket route: 510(k).
How long does a 510(k) take for product code MXZ?
Across 13 cleared submissions the average was 141 days from receipt to decision (median 119).
Which companies have the most MXZ clearances?
Leica Biosystems Newcastle, Limited (2); Dako North America, Inc. (2); Leica Biosystems Newcastle, Ltd. (1); Dako Denmark A/S (1); Ventana Medical Sytems, Inc. (1).
Have MXZ devices been recalled?
Yes: 3 product recalls across 2 recall events; the most recent began 2018-08-02.
Next steps
- Run an FDA pathway report with predicate devices for product code MXZ
- Run a recall and safety report across every MXZ manufacturer
- Watch product code MXZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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